POS1212 SARS-CoV-2 VACCINE SAFETY IN ADOLESCENTS WITH INFLAMMATORY RHEUMATIC AND MUSCULOSKELETAL DISEASES AND ADULTS WITH JUVENILE IDIOPATHIC ARTHRITIS
Authors: S. Lawson-Tovey, A. Strangfeld, E. Mateus, L. Gossec, L. Carmona, P. Machado, B. Raffeiner, I. Bulina, D. Clemente, J. Zepa, A. M. Rodrigues, X. Mariette, K. Hyrich
Journal: Annals of the Rheumatic Diseases (2022)

Background There is a lack of data on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs. Objectives To describe the characteristics and outcomes of adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA) vaccinated against SARS-CoV-2. Methods We described patient characteristics, flares, and adverse events in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology (EULAR) COVAX registry. Results Thirty-six adolescent cases were reported from 4 countries, the most frequent diagnosis was JIA (42%). Over half (56%) reported early reactogenic-like adverse events (AEs) experienced within 7 days of vaccination. One mild polyarthralgia flare and one serious AE (malaise) were reported. No CYP reported SARS-CoV-2 infection post-vaccination. In addition to the adolescent cases, eleven countries reported 74 adult JIA cases. Among these, 62% reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three 20-30 year old females were diagnosed with SARS-CoV-2 post-vaccination; all fully recovered. Conclusion In this observational registry dataset, SARS-CoV-2 vaccines appeared safe in adolescents with RMDs and adults with JIA, with a low frequency of disease flares, serious AEs, and SARS-CoV-2 re-infection seen in both populations. Table 1. Characteristics of adolescents with RMDs and adults with JIA reported to the EULAR COVAX registry Adolescents with RMDs (N=36) Adults with JIA (N=74) Sex Female 21 (58) 54 (73) Male 15 (42) 20 (27) Age (median [IQR]) 15 [14.5, 17] 26 [23, 31] Primary RMD diagnosis Non-systemic JIA 10 (28) 63 (85) Systemic JIA 5 (14) 11 (15) Systemic lupus erythematosus 5 (14) Spondyloarthritis/psoriatic arthritis 5 (14) Vasculitis/other RMD # 11 (30) RMD disease activity Remission 23 (64) 33 (45) Minimal 8 (22) 21 (28) Moderate 2 (6) 12 (16) Severe 1 (3) 1 (1) Not applicable/missing 2 (6) 7 (10) RMD medication None 9 (25) 3 (4) b-DMARD 9 (25) 50 (68) cs-DMARD 21 (58) 25 (34) ts-DMARD 5 (14) 2 (3) Systemic glucocorticoids 5 (14) 1 (1) Colchicine 7 (10) Other immunosuppressant * COVAX type Pfizer/BioNTech 33 (92) 50 (68) Moderna 2 (6) 10 (14) AstraZeneca/Oxford 1 (3) 10 (14) Janssen 1 (1) CoronaVac 2 (3) UNK 1 (1) COVAX doses 1 11 (31) 8 (11) 2 2 (24) 61 (82) 3 1 (3) 5 (7) RMD flare Yes 1 (3) 2 (3) AE Yes 20 (56) 46 (62) Early AE Injection site pain 8 (22) 16 (22) Redness 6 (17) 2 (3) Muscle pain 1 (3) 9 (12) Joint pain 4 (11) 3 (4) Headache 9 (25) 10 (14) Fever 1 (3) 26 (35) Chills 2 (6) 5 (7) Fatigue 1 (3) 13 (18) Vomiting AE of special interest Non-serious 1 (3) 1 (1) Serious – important medical event 1 (3) All data are N(%) of the column unless stated otherwise. # Other RMD includes Sjogren’s syndrome, systemic sclerosis, undifferentiated connective tissue disease, non-monogenic auto-inflammatory syndrome, chronic recurrent multifocal osteomyelitis, and other inflammatory arthritis * Other immunosuppressant includes ciclosporin, mycophenolate mofetil/mycophenolic acid. RMD, rheumatic and musculoskeletal disease; JIA, juvenile idiopathic arthritis; EULAR, European Alliance of Associations for Rheumatology; ANCA-associated vasculitis, anti-neutrophil cytoplasmic antibody-associated vasculitis; cs-, conventional synthetic; b-, biological; ts-, targeted synthetic; DMARD, disease-modifying anti-rheumatic drug; COVAX, Coronavirus vaccine; AE, adverse event. Acknowledgements We wish to thank all healthcare providers who entered data into the registry. Disclosure of Interests Saskia Lawson-Tovey: None declared, Anja Strangfeld Speakers bureau: AbbVie, MSD, Roche, BMS, Pfizer, Elsa Mateus: None declared, Laure Gossec Consultant of: AbbVie, Amgen, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Lilly, Pfizer, Sandoz, Loreto Carmona: None declared, Pedro Machado Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, UCB, Consultant of: AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, UCB, BERND RAFFEINER: None declared, Inita Bulina Speakers bureau: AbbVie, Pfizer, Janssen, Boehringer Ingelheim, Daniel Clemente Speakers bureau: Novartis, GSK, Julija Zepa Speakers bureau: AbbVie, Novartis, Janssen/Johnson &amp; Johnson, Ana Maria Rodrigues Speakers bureau: Amgen, AbbVie, Grant/research support from: Amgen, Pfizer, AstraZeneca, Xavier Mariette Consultant of: BMS, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sanofi-Aventis, UCB, Grant/research support from: Ose, Kimme Hyrich Speakers bureau: AbbVie, Grant/research support from: Pfizer, BMS, UCB